Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes

Peking University

Status and phase: Completed; Phase 4

Conditions: Postoperative Complications; High-risk Patients; Dexmedetomidine; Abdominal Surgery; Blood Pressure

Treatments: Drug: Dexmedetomidine; Drug: Placebo; Other: Goal-directed blood pressure management; Other: Routine blood pressure management

Study type: Interventional

Funder types: Other

Identifiers

NCT03933306

2019-73

Details and patient eligibility

About

Perioperative organ injuriy remain an important threat to patients undergoing major surgeries. Intraoperative hypotension is associated with an increase in postoperative morbidity and mortality. Whereas individualized intraoperative blood pressure management is likely to decrease the incidence of postoperative organ injury when compared with standard blood pressure management strategy. Dexmedetomidine, a highly selective alpha2 adrenergic agonist, has been shown to provide organ protective effects. This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on incidence of postoperative organ injury in high-risk patients undergoing major surgery.

Full description

The number of patients undergoing surgeries is increasing worldwide. However, some patients develop complications or even die after surgery. Perioperative organ injury is the leading cause of the unfavorable outcomes.

Hypotension is not uncommon during major surgery and is highly responsible for the inadequate perfusion and organ injury. A recent study showed that individualized blood pressure management decreases the incidence of postoperative organ injury when compared with standard blood pressure management strategy.

Dexmedetomidine is a highly selective alpha2 adrenergic agonist. Previous studies showed that dexmedetomidine provides organ protection in various conditions. In a recent meta-analysis, perioperative dexmedetomidine reduceds the occurrence of postoperative delirium. However, whether it can reduce postoperative complications remains inconclusive.

This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on the incidence of postoperative organ injury in high-risk patients undergoing major abdominal surgery.

Enrollment: 496 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 50 years or older;
• Scheduled to undergo abdominal surgery under general anesthesia with an expected duration of 2 hours or longer;
• With a preoperative acute kidney injury risk index of class III or higher (meet 4 or more of the following factors: age ≥56 years, male sex, active congestive heart failure, ascites, hypertension, emergency surgery, intraperitoneal surgery, mild or moderate renal insuffificiency, diabetes mellitus requiring oral or insulin therapy).

Exclusion criteria

• Severe uncontrolled hypertension (SBP>180 mmHg or diastolic blood pressure >110 mmHg);
• Acute or decompensated heart failure, acute coronary syndrome, or stroke within 1 month;
• Severe bradycardia (heart rate < 50 bpm), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker, atrial fibrillation, or frequent premature beats;
• Severe hepatic dysfunction (Child-Pugh C) or chronic kidney disease (glomerular filtration rate <30 ml/min/1.73 m2 or dependent on renal replacement therapy) ;
• Pregnant;
• Receiving dexmedetomidine or norepinephrine infusion before surgery;
• Do not provide written informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

496 participants in 4 patient groups, including a placebo group

Placebo+routine blood pressure management

Placebo Comparator group

Description:

Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.

Treatment:

Other: Routine blood pressure management

Drug: Placebo

Dexmedetomidine+routine blood pressure management

Experimental group

Description:

Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is managed according to routine practice.

Treatment:

Other: Routine blood pressure management

Drug: Dexmedetomidine

Placebo+goal-directed blood pressure management

Experimental group

Description:

Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.

Treatment:

Other: Goal-directed blood pressure management

Drug: Placebo

Dexmedetomidine+goal-directed blood pressure management

Experimental group

Description:

Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.

Treatment:

Other: Goal-directed blood pressure management

Drug: Dexmedetomidine